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FDA 510(k)

FUJIFILM Double Balloon Endoscope EI580BT

K-Number: K183032 · 2019-06-24

ApplicantFujifilm Corporation
Decision Date2019-06-24
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Double Balloon Endoscope EI580BT is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-06-24 under 510(k) number K183032. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Double Balloon Endoscope EI580BT?

FUJIFILM Double Balloon Endoscope EI580BT is a medical device that received FDA 510(k) clearance on 2019-06-24. The listed applicant is Fujifilm Corporation. The 510(k) number is K183032.

When did FUJIFILM Double Balloon Endoscope EI580BT receive FDA 510(k) clearance?

FUJIFILM Double Balloon Endoscope EI580BT received FDA 510(k) clearance on 2019-06-24, under 510(k) number K183032.

Who is the listed applicant for FUJIFILM Double Balloon Endoscope EI580BT?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Double Balloon Endoscope EI580BT?

The FDA product code for FUJIFILM Double Balloon Endoscope EI580BT is FDA.

Other records listing Fujifilm Corporation as applicant

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K261170BA-004CCK260567EW10-EC02 Endoscopy Support ProgramK261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TK254075Synapse Lung Nodule AIK254189Synapse 3D Base Tools (V7.2)

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Related Devices (Code: FDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260314Ancora-SBAspero Medical, Inc.K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas CorporationK233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas CorporationK231323Ancora-SBAspero Medical, Inc.K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm CorporatonK213195Balloon BS-3Fujifilm Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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